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This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to placebo therapy.
Experimental: ALLO-ASC-DFU, Placebo Comparator: Vehicle Sheet, Study type: Interventional, Study design: Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALLO-ASC-DFU | Experimental | Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells |
|
| Vehicle Sheet | Placebo Comparator | Hydrogel sheet without Allogenic mesenchymal stem cell |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLO-ASC-DFU | Biological | Application of ALLO-ASC-DFU sheet to diabetic foot ulcer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportions of subjects who achieved complete wound closure | During 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time taken to complete wound closure between the two groups | During 12 weeks | |
| Proportions of subjects who achieved complete wound closure | Follow up to 12 weeks | |
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Inclusion Criteria:
Subject is between 18 and 75 years of age.
Subject is diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
Foot ulcer size is between 1 cm2 and 15 cm2
Ulcer graded I or II by Wagner grade, and extended to skin, tendon, and subcutaneous tissue.
Free of necrotic debris at target ulcer
Around ulcer area blood circulation should be secured to meet one of below criteria;
Subject is able to give written informed consent prior to study start and to comply with the study requirements during study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seung-Kyu Han, MD. Ph D. | Korea University Guro Hospital | Principal Investigator |
| Ki-Won Young, MD. Ph D. | Eulji General Hospital | Principal Investigator |
| Junpyo Hong, MD. Ph D. | Asan Medical Center | Principal Investigator |
| Donghyeok Shin, MD. Ph D. | Konkuk University Medical Center | Principal Investigator |
| Junhyeong Kim, MD. Ph D. | Keimyung University Dongsan Medical Center | Principal Investigator |
| Kang Chan, MD. Ph D. | Chungnam National University Hospital | Principal Investigator |
| Hyungmin Hahn, MD. Ph D. | Ajou University Medical Center | Principal Investigator |
| Changsik Park, MD. Ph D. | Seoul National University Bundang Hospital | Principal Investigator |
| Youngkoo Lee, MD. Ph D. | Soonchunhyang University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Kuro Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| Vehicle sheet | Procedure | Application of Vehicle sheet to diabetic foot ulcer |
|
|
| Proportions of subjects who achieved complete wound closure by the classification of Wagner Grade between the two groups |
| Follow up to 12 weeks |
| Change rates in wound size and depth compared to baseline between the two groups | cm^2 | During 12 weeks |
| Proportions of subjects who achieved complete wound closure at every visit by the classification of ulcer locations | Follow up to 12 weeks |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |